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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022290
Receipt No. R000025268
Scientific Title Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Date of disclosure of the study information 2016/07/01
Last modified on 2017/05/23

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Basic information
Public title Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Acronym Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Scientific Title Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Scientific Title:Acronym Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Region
Japan

Condition
Condition Reflux esophagitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare acid inhibitory effect of Vonoprazan and that with Lafutidine.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome is acid inhibition with the three regimens as assessed by 24-hour intragastric pH monitoring on Day7 in each regimen.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 There are three regimens as follows; (1) Vonoprazan 20mg once daily for 7 days, (2) Vonoprazan 10mg once daily for 7 days, (3) Vonoprazan 10mg and Lafutidine 10mg once daily for 7 days. Subujects receive the three different regimens in a crossover manner. The order of the four regimens is randomized as interventions 1-24. Interventions 16-24 are mentioned in other related information, because of lack of the space.

A clinical research coordinator manages the dosing schedule of each subject. The washout period between the different regimens is at least 2 weeks. In each regimen, 24-h intragastric pH monitoring is performed on Day7.
Interventions 1; regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (3).
Interventions/Control_2 Interventions 2; regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (2).
Interventions/Control_3 Interventions 3; regimen (2), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (3).
Interventions/Control_4 Interventions 4; regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (1).
Interventions/Control_5 Interventions 5; regimen (3), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (2).
Interventions/Control_6 Interventions 6; regimen (3), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (1).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy Japanese men and women.
Key exclusion criteria Exclusion criteria are any underlying disease, smoking habit, past or present H.pylori infection, and habitual use of any medicine.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Suzuki
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2111
Email takahr99@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Furuta
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2261
Homepage URL
Email furuta@hama-med.ac.jp

Sponsor
Institute First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Institute
Department

Funding Source
Organization First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 浜松医科大学(静岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 02 Month 24 Day
Date of closure to data entry
2017 Year 02 Month 24 Day
Date trial data considered complete
2017 Year 02 Month 24 Day
Date analysis concluded
2017 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 12 Day
Last modified on
2017 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025268

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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